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2 Seafood HACCP Alliance Segment Two Course

Course Number:

Course Location:

Course Date:

AFDO Region:

Instructor:

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2 AGENDA (SHA Segment 2 Course)

PART 1: Lecture and Discussion▪ FDA Seafood HACCP Regulation

▪ Seafood Safety Hazards & Controls

▪ Developing a HACCP Program

PART 2: Course Work Assignment▪ Team Work Groups & Presentations

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2 Purpose of this Training

Individuals who complete this course will meetthe training requirement of the FDA Seafood HACCP regulation and can do the following:

▪ Develop a HACCP Plan for seafood products as required by the FDA regulation

▪ Reassess or modify a HACCP Plan as necessary and/or required by the FDA regulation

▪ Review HACCP Plan records as required by the FDA regulation

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2 Expectations for Training

▪ Seafood HACCP Alliance courses provide a basic introduction to prevailing regulatory requirements for HACCP as required for processing seafood and aquaculture products

▪ Practice to learn how to use the FDA Guidance manual in conducting Hazard Analysis and developing a HACCP Plan

▪ Explanation and examples for how to monitor the required Sanitation Control Procedures

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2 SHA Training Materials

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2

▪ FDA Seafood HACCP Regulation21 CFR Part 123

https://www.fda.gov/food/hazard-analysis-

critical-control-point-haccp/seafood-haccp

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2

FDA Seafood HACCP Regulation21 CFR Part 123

▪ Any fish or fishery products processed or imported in violation of this regulation can be considered adulterated and subject to regulatory action

▪ A processor is any person engaged in commercial, custom or institutional processing of fish or fishery products either in the U.S. or in a foreign country

▪ Specific requirements for importers - the U.S. owner/consignee or the U.S. agent/representative of the foreign owner/consignee at the time of the product entry into the United States

211 A8-1

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What Does Processing Include?

▪ Processing means: Handling, storing, preparing, heading, freezing, eviscerating, changing to different market forms, manufacturing, shucking, preserving, packing, labeling, dockside unloading, or holding.

▪ The regulation does not apply to: ▪ Harvesting,▪ Transporting, ▪ Heading, eviscerating or freezing on a harvest vessel

intended solely to hold the fish,▪ Retail operations.

A8-2

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2

What are fish or fishery products?

▪ Fish means: fresh or salt water finfish, crustaceans, mollusks, other forms of aquatic animal life (e.g. alligator, frog, aquatic turtle, jellyfish, sea cucumber, sea urchin, roe), other than birds or mammals.

▪ Fishery product means: any food product where fish is a characterizing ingredient.

▪ All products intended for human consumption are covered.

A8-2

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2

What MUST all processors do?

▪ Complete a Hazard Analysis to determine if there are any significant hazards associated with your products or process

▪ Develop and implement a HACCP Plan to control any significant food safety hazards that are identified

▪ Monitor and keep records of monitoring results and

corrections taken for 8 specified areas of sanitation

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What MUST all processors do?A8-3

HACCP

SCP’s

GMP’s 117

Processors are required to develop and maintain a HACCP program based on a pre-requisite foundation of Sanitation Control Procedures and the Good Manufacturing Practices (GMP’s)

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Sanitation Control Procedures (SCPs)

HACCP

SCP’s

GMP’s 117

▪ Seafood processors are required to practice, monitorand record SCP’s during all processing operations

▪ As of 2016, the SCP’s must be based on the most current Good Manufacturing Practices Part 117 that replaced GMP’s 110

SCP’s are not featured in this Segment 2 HACCP course, but they are the essential and required foundation for all HACCP Programs

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2

Processors must monitor and keep records of monitoring results and corrections for 8 key areas of sanitation:

1. Safety of water;2. Condition & cleanliness of food contact surfaces;3. Prevention of cross contamination;4. Maintenance of hand washing, hand sanitizing, and toilet facilities;5. Protection of food, food packaging material, and food contact

surfaces from adulteration;6. Proper labeling, storage, and use of toxic compounds7. Control of employee health conditions8. Exclusion of pests from the food plant.

A8-8 Sanitation Control Procedures (SCPs)

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Sanitation Control Procedures (SCPs)

Example Written SCP Plans and Monitoring Records

SOURCE: FL Sea Grant website: https://www.flseagrant.org/seafood/haccp/

SCP Curriculum

SHA Curriculum

BLUE BOOKGREEN BOOK

Chap 2: 30-40

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2

Sanitation Control Procedures (SCPs)

The new GMPs 117 introduced additional requirements for all seafood processors:

▪ Seafood processors are required to assess and record any necessary SCP controls to prevent ‘cross-contact’ of potential food allergens

▪ Additional employee training requirements must be documented

HACCP

SCP’s

GMP’s 117

Appendix 3

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2

Sanitation Control Procedures (SCPs)

▪ Records for additional training are required for all workers in the processing operations

▪ There are no prescribed courses and performance remains the primary measure for effective training, but training records are mandatory

EMPLOYEE TRAINING RECORDSChap 2: 13

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2

Required parts of a HACCP Program ?

▪ Shall conduct a Hazard Analysis to determine if there are any significant hazards associated with your products or process.

▪ Develop and implement a HACCP Plan to control any significant food safety hazards that are identified.

A8-3

HACCP

SCP’s

GMP’s 117

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HACCP Plan Requirements

▪ Each of the 7 principles of HACCP has a section in the FDA regulation with specific requirements related to that principle.

▪ HACCP Plans must be specific for:- Each kind of fishery product

(products can be grouped if hazards & controls are the same)- Each processing location

▪ HACCP Plans must be signed, dated & routinely implemented.

A8-4

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2

Review of 7 HACCP Principles

Conduct a Hazard Analysis:

Principle 1 – Conduct a Hazard Analysis

Principle 2 – Identify Critical Control Points

Build a HACCP Plan

Principle 3 – Set Critical Limits

Principle 4 – Establish Monitoring Procedures

Principle 5 – Establish Corrective Action Procedures

Principle 6 – Establish Verification Procedures

Principle 7 – Establish a Record Keeping System

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Species-Related Hazards

Process-Related Hazards

▪ Seafood Safety Hazards & Controls

SEAFOOD

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2

“Reasonably Likely” Seafood Hazards

SPECIES-Related Hazards

▪ Pathogens (harvest)▪ Parasites▪ Natural Toxins▪ Histamine (elevated)▪ Environmental Chemicals▪ Aquaculture Drugs

Vertebrates

Invertebrates

Table 3-2

(page 3-3)

Table 3-3

(page 3-37)

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2

“Reasonably Likely” Seafood Hazards

PROCESS-Related Hazards ▪ Pathogen Bacteria Growth

–Temperature Abuse▪ C. botulinum toxin▪ S. aureus Toxin –Drying▪ S. aureus Toxin –Batter▪ Pathogen Bacteria Survival through

Cooking and Pasteurization▪ Pathogen Bacteria Survival through

Processes Designed to Retain Raw Product Characteristics

SEAFOOD

▪ Pathogenic Bacteria Contamination ▪ After Pasteurization and Specialized

Cooking Processes▪ Allergens and Food Intolerance

Substances▪ Metal Inclusion▪ Glass Inclusion

Table 3-4

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SEAFOOD

In HACCP regulations processors are responsible for Hazard Controls, so it is important to understand the difference between primary and secondary processing

PRIMARY PROCESSOR

NOTE

SEAFOOD

SECONDARY PROCESSOR

FARMED

WILD

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2

Discuss Seafood Hazards & Controls

GOLD BOOK

FDA GUIDE

Each ‘potential’ seafood safety hazard and recommendations for respective control options are briefly explained in the FDA Guide

▪ How can processors determine which ‘potential’ hazards should be considered for their species and products?

▪ How can the hazards and controls vary for primary and secondary processors?

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2 Parasites:Hazard: Living parasites in certain fish or shellfish species that can infect humans Controls: Cooking by or for consumers or proper freezing HACCP Controls: A processor must properly freeze products that are likely to contain parasites if they will be consumed raw or partially cooked (e.g. sushi, sashimi etc.)

Harvest Pathogens:Hazard: Harvest waters can have high pathogen levels that contaminate shellfish or some fishControls: Cooking by or for consumers and restricting harvesting to approved waters with safe pathogen levelsHACCP Controls: Bivalve molluscan shellfish are only harvested from approved waters and all processors ensure products are properly tagged or labelled to ensure traceability

Species-Related Food Safety Hazards91

75

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Species-Related Food Safety Hazards

Histamine or Scombrotoxin: Hazard: Elevated histamine levels can develop in certain fish species exposed to time and temperature abuse

Controls: Prevent time and temperature abuse

HACCP Controls: All processors must prevent time and temperature abuse in fish species likely to develop scombrotoxin

Natural Toxins:

Hazard: Naturally occurring toxins can accumulate in shellfish and finfish harvested from contaminated watersControls: Prohibit harvesting from contaminated waters

HACCP Controls: Primary processors must confirm that the products they receive were not harvested from contaminated waters

113

6-1

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Species-Related Food Safety Hazards

Environmental Chemical Pollutants/Contaminants:

Hazard: Environmental or industrial chemicals can accumulate in finfish or shellfish harvested from polluted watersControls: Prohibit harvesting from contaminated watersHACCP Controls: Primary processors must confirm that the products they receive were not harvested from waters that have a health advisory because of pollution

Aquaculture Drugs: Hazard: Drugs used in aquaculture facilities must be approved and properly usedControls: Prohibit use of unapproved drugs and follow expert advice on proper use of approved drugsHACCP Controls: Primary processors must confirm that the products they receive from aquaculture suppliers are following proper practices

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2Process-Related Food Safety Hazards

Pathogen Growth caused by time/temperature abuse:Hazard: Pathogen growth in products that will not be cooked before they are consumed could cause consumer illness

Controls: Prevent time and temperature abuse of ready to eat products (e.g. cooked, salads, smoked products, pasteurized, sushi etc.)

HACCP Controls: All processors must prevent time and temperature abuse in ready to eat products that will not be cooked before consumption

Clostridium botulinum toxin production: Hazard: C. bot can grow in smoked, salted & pickled products and products packed in reduced oxygen packages(ROP) that are subjected to time and temperature abuse

Controls: Prevent time and temperature abuse of smoked, salted, pickled and ROP products

HACCP Controls: All processors must prevent time and temperature abuse in smoked, salted, pickled and ROP packed products

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Process-Related Food Safety Hazards

Staph. aureus toxin production:Hazard: S. aureus can grow in battered and salted products that are subjected to time and temperature abuseControls: Prevent time and temperature abuse HACCP Controls: Processors must prevent time and temperature abuse during manufacture of battered and salted products

Cooking, Pasteurization and Non-thermal Processes:Hazard: Improperly cooked, pasteurized or non-thermally processed foods can contain pathogens and cause consumer illnessControls: Scientifically validated cooking, pasteurization, or non-thermal processes must be used to kill all pathogensHACCP Controls: Processors must continuously monitor their cooking, pasteurization, or non-thermal processes to ensure that pre-determined validated limits have been met

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Process-Related Food Safety Hazards

Food Intolerance Substances:Hazard: Sulfites and some coloring agents can cause a food intolerance reaction in some consumers Controls: Products that contain food intolerance substances must be properly labeled to alert consumers HACCP Controls: Processors must ensure that products that contain food intolerance substances are properly labeled

Undeclared Food Allergens:Hazard: All finfish and crustaceans are considered a major food allergenControls: Fish and crustaceans or products that contain them must be labeled with their correct market nameHACCP Controls: Processors must ensure that all containers or packages that contain fish and crustaceans are labeled with their correct market name

19-1

19-1

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2Process-Related Food Safety Hazards

Metal Inclusion in finished products: Hazard: Undetected metal fragments in food can cause physical injury to consumers Controls: Metal detection if it is likely that manufacturing machinery could introduce undetected metal fragments into foodHACCP Controls: Processors must pass all finished packages through a metal detector or use an equivalent method to ensure that contaminated products are not sold

Glass inclusion in finished products: Hazard: Undetected glass fragments in food can cause physical injury to consumers Controls: Glass containers must be inspected to ensure that glass has not contaminated the food HACCP Controls: Processors must inspect glass containers to detect breaking, cracking or other types of glass contamination to ensure that contaminated products are not sold

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Recommended Controls from the FDA Guide

▪ Background information▪ Identifying CCP’s▪ Different Control Strategies

▪ Critical Limits▪ Monitoring▪ Corrective Actions▪ Records▪ Verifications

▪ Example HACCP Plans▪ References

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▪ Developing a HACCP Program

CCPs

HACCP Plan =

Hazard Analysis =

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Building the HACCP Plan

SHA Curriculum

BLUE BOOK

The Blue Book provided an example for how to develop a HACCP Plan

Chap 4: 69 – Mahi Fillets

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Building the HACCP Plan

The Segment 2 course will explain how the HACCP plan was developed using the recommendations in the FDA Guide

GOLD BOOK

FDA GUIDE

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Preliminary Step 1. Assemble the HACCP Team

Managers Sanitation

Processing

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Preliminary Step 2. Describe Product

Blue Book provides a useful form for preliminary information

Chap 4: 74

Appendix 2

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Preliminary Step 3. Process Flow Chart

Chap 4: 75

Develop a Process Flow Diagram and understand or describe what happens at each step (Process Narrative)

Example: Fresh Mahi-mahi fillets

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A brief processing narrative can be used to help explain the Processing Flow Chart

▪ Market Name: Mahi-mahi

▪ Source: Wild caught; received from other processors

▪ Finished Product Form: Raw fillets

▪ Receiving, Storage & Distribution Method: Iced

▪ Packaging: Exposed to air, not reduced oxygen packed

▪ Intended Use: To be cooked before eaten

▪ Intended Consumer: General public

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Required Hazard Analysis

GOLD BOOK

FDA GUIDE

Use the preliminary information▪ Process Description▪ Processing Flow Chart▪ Accompanying process narrative

with recommendations from the

FDA Guide beginning with a Hazard Analysis Worksheet Appendix 2

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Hazard Analysis Worksheet

ReceivingStep

RefrigeratedStorageStep

TrimStep

Weigh/PackLabel Step

FinalRefrigeratedStorageStep

Column 1: List all

of the processing

steps from the

Process Flow Chart

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Use the FDA Hazard Guide to help identify the potential hazards for analysis

“… guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations …”

Recommendations lead tosuccessful compliance

GOLD BOOK

FDA GUIDE

A8-3

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Search for the potential hazards for the Fresh ‘Wild’ Mahi-mahi Fillets (XYZ Seafood Company)

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Table 3-4

Processing-Related

Hazards

Tables 3-2 and 3-3

Species-Related

Hazards

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One Species-related hazardTable 3-2

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Four Process-related HazardsTable 3-4

Notice two

hazards in

Chapter 19

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Hazard Analysis for the XYZ Seafood Company should include 5 potential hazards:

Species-related Hazards (Table 3-2)

1. Histamine formation (Chapter 7)

Process-related Hazards (Table 3-4)

2. Pathogenic bacterial growth-temperature abuse(Chapter 12)

3. Allergens (Chapter 19)

4. Food Intolerance Substances (Chapter 19)

5. Metal inclusion (Chapter 20)

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Inclusive Method

Every potential hazard considered at each processing step

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Exercise - Complete the Hazard Analysis Worksheet

Simply answer the questions in order for each listed potential hazard at each processing step

FDA Guide provides some recommendations in the respective hazard chapters

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Column 2Potential Hazards(Likely to Occur)

Columns 3 & 4Is the hazard significant in this

processing operation

Column 5Necessary Controls

Histamine YESMahi is potential scombrotoxic fish species subject to temperature abuse

Time and Temperature controls (Chapter 7)

Pathogen Growth-Temp. Abuse

NOMahi intended to be cooked before consumption

Chapter 12

Undeclared Food Allergens

YES Fish are food allergensProper product labeling(Chapter 19)

Food Intolerance Substances (FIS)

NONo FIS or food additives used or addedin this processing operation

Metal Inclusion NO Not likely to occur in processing steps Chapter 20

BRIEF SUMMARY based on the FDA Guide that provides more recommended details

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Completed Hazard Analysis

Worksheet

Page 1CCP

CCP

Completed

Hazard Analysis

105 - 107

NOTE: Every ‘Yes’ in

column 3 requires a

response in column 6

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Completed Hazard Analysis

Worksheet

Page 2

Completed

Hazard Analysis

105 - 107

NOTE: Every ‘Yes’ in

column 3 requires a

response in column 6

CCP

CCP

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Conclusions from the Hazard Analysis

▪ Histamine is a significant food safety hazard and there are three CCPs for this hazard:

CCP 1. Receive fresh fish

CCP 2. Refrigerated storage, and

CCP 3. Finished product refrigerated storage

▪ Food allergens is a significant food safety hazard and there is one CCP for this hazard:

CCP 4. Weigh/Pack/Label

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Building the HACCP Plan

Appendix 2

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Optional HACCP Plan Forms (both must contain same information)

Landscape

Appendix 2

101 and 102

Portrait

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Set up a HACCP Plan Form for each CCP

Column 1 & 2: List all

of the identified CCPs

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Principle 3: Set Critical Limits using theFDA Hazards Guide

Chap 7: 125

CONTROL STRATEGYselected from the FDA Guide

CCP – ReceivingHazard - Histamine

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Principle 3: Set Critical Limits using theFDA Hazards Guide

Chap 7: 137TRANSIT CONTROL OPTIONS

• Transit temperature records, or• Surrounded by ice on delivery, or• Use of ice; AND internal fish temperature, or• Frozen gel-packs; AND internal fish temperature, or

• Transit time (< 4 hours); AND internal fish temperature

Tip Notice ‘ORs & ANDs ’

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CRITICAL LIMITS

Based on recommendations in the FDA Guide

Chap 7: 137- 138

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Principle 4: Establish Monitoring Procedures

Follow the same option selected for Critical Limits

Example: Control Strategy = Transit control

Critical Limit Option: Surrounded by ice

• What will be monitored?

• How will monitoring be done?

• How often will monitoring be done (frequency)?

• Who will do the monitoring?

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MONITORING121

Based on FDA Guide

Chap 7: 138

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Follow the same option selected for Critical Limits

Example: Control Strategy = Transit control

Critical Limit Option: Surrounded by ice

Corrective Actions with two parts (‘IF’ & ‘THEN’) should include actions to assure safe products and to fix the problem before further processing

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(page 1) CORRECTIVE ACTIONS132

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(page 2) CORRECTIVE ACTIONS133

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Select the Verification options that apply to the critical limit chosen:

• Weekly record review applies to all options

• Thermometers must be checked for accuracy and periodically calibrated

Principle 6: Establish Verifications

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(page 1) VERIFICATIONS149

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(page 2) VERIFICATIONS150

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Principle 7: Establish Record Keeping Procedures

Enter the name of the records that will be kept for that CCP on the HACCP Plan Form

Your Records must be designed to meet the requirements of 21 CFR Part 123.9 to document the results of the Monitoring, Corrective Action, and Verification components of the HACCP Plan

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(page 1) RECORDS173

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(page 2) RECORDS174

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Complete HACCP Plan 173 - 178

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HACCP Plans can be built for any Hazard in the same way using the appropriate chapter in the FDA Hazards Guide

✓ Select the Control Strategy that applies to your situation & CCP

✓ Select one or more Critical Limit options for your situation

✓ Follow the same option(s) to determine Monitoring, Corrective Action, Verification and Record keeping procedures

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Other Resources in the FDA Hazards Guide

▪ Appendix 1 (page 406-409) Blank Forms

▪ Appendix 4 (page 417-423) Bacterial Pathogen Tables

Table A-1 (p.420) Limiting Conditions for Growth

Table A-2 (p.421) Cumulative Time & Temp. Exposure

Table A-3 (p.422) Cooking (Inactivation of L. mono)

Table A-4 (p.423) Pasteurization (Inactiv. Of C. bot B)

▪ Appendix 5 (p.440-441) FDA & EPA Safety Levels in Guidance and Regulations

▪ Appendix 8 (p.455-468) FDA Seafood HACCP Regulation 21 CFR Part 123

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WORK SESSIONS

Each Group will:

▪ Get organized: choose a leader, scribe & presenter

▪ Read and review the Preliminary Steps Handout (product description, process narrative, & process flow chart for the model)

▪ Conduct Your Hazard Analysis:▪ Set up a Hazard Analysis Worksheet (fill in heading & Column 1 –

enter all process steps from Process Flow Diagram)▪ Look up all potential Species & Process Hazards in Tables 3-2, 3-3 &

3-4 in the FDA Hazards Guide and enter results in Column 2▪ Determine which potential hazards are significant using Chapters 4-

21 of the FDA Hazards Guide and enter results in Columns 3 and 4▪ For all significant hazards identify control measures in Column 5 ▪ Determine if each step is a CCP for the significant hazards that you

have identified using Chapters 4-21 of FDA Hazards Guide.

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WORK SESSIONS -continued

Each Group will:

Develop a HACCP Plan for each significant hazard at each CCP identified in the Hazard Analysis by completing the following: ▪ Set up a HACCP Plan Form by filling in company & product

information and columns 1 and 2 (CCP and Hazard) ▪ Identify a Control Strategy and the corresponding Critical Limit

using Chapters 4-21 in FDA Hazards Guide and enter result in Column 3

▪ Complete the HACCP Plan Form by identifying the appropriate monitoring, corrective action, verification and records associated with the Control Strategy that was selected from Chapters 4-21. Enter the results in Columns 4-10 of the HACCP Plan Form

Finalize your group’s results for presentation to the rest of the class and determine who from your group will do the presentation.

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WORK SESSIONS -continued

Finally, to complete the learning process,

Each Group will present results for their Hazard Analysis and HACCP plans for open course discussion

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QUESTIONS